VR-assisted CBT for Adolescents With Psychosis

Psychotic Disorders Clinical Trial

Official title:

VR-assisted Cognitive Behaviour Therapy for Adolescents With Psychosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04586868
• Other study ID #: 95428
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Haukeland University Hospital
• Contact: Anita Barsnes, MA
• Phone: 004790922186
• Email: anita.barsnes[@]helse-bergen.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Psychotic disorders typically emerge during late adolescence or early adulthood. Patients, who are diagnosed with a psychotic disorder before turning 18 years, are defined as early onset psychosis patients (EOP). Relative to adult patients, these patients show a worse long-term prognoses. Social impairment present a major barrier towards recovery, and thus and important issue to address in treatment. Cognitive behavioral therapy (CBT) is the recommended psychological treatment for psychotic disorders. As part of the therapy, the patient does an exposure-based training in a social environment. This type of training has several limitations for patients with psychosis. The last decade there has been a growing interest in using virtual reality (VR) to understand and treat various psychological disorders. There is a lack of research on VR-interventions for EOP patients. This study will assess the acceptability, tolerability, feasibility and clinical efficacy of a novel VR-assisted CBT interventions for adolescents with psychosis.

Description:

This study adhere to the model for research made by the international Virtual Reality Clinical Outcomes Research Experts groups (VR-CORE). The study consist of three sub-studies. First a qualitative study assessing the acceptability for VR among adolescence with psychosis. Secondly, a randomized study of the feasibility of virtual reality environment for adolescents with psychosis. Third, assessing the clinical efficacy of a novel VR-assisted CBT interventions for adolescents with psychosis, through a non-randomized single-case study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

Inclusion Criteria:

• Suffering from a psychotic disorder (ICD-10 WHO)
• In stable clinical condition (i.e. not hospitalized)
• Being able to speak Norwegian or a Scandinavian language, or English
• Able to provide informed consent.

Exclusion Criteria:

• Primary neurological or endocrinological disorder
• Started a "transfer-process" to Department of Adult Psychiatry.

Related Conditions & MeSH terms

• Mental Disorders
• Psychotic Disorders

Intervention

Behavioral:
• An intervention development study
Assessing the acceptability for a virtual reality intervention among adolescents with psychosis
• A randomized feasibility study
Feasibility of virtual reality environment for adolescents with psychosis
• A single-case study
The clinical efficacy of a novel VR-assisted CBT interventions for adolescents with psychosis

Locations

Country	Name	City	State
Norway	Haukeland university hospital	Bergen

Sponsors (2)

Lead Sponsor	Collaborator
Haukeland University Hospital	Helse Stavanger HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Level of functioning	Children's Global Assessment Scale (C-GAS)	1 week after treatment.
Primary	Acceptability for a virtual reality intervention	Semi-structured interview	5 months
Primary	Social self-efficacy	Adolescent self-efficacy scale (S-EFF)	1 week before, and 10 minutes after treatment.
Primary	Social interaction and social phobia	Short Form Social Interaction Anxiety Scale/Social Phobia Scale (SIAS-6/SPS-6)	1 week before, and 10 minutes after treatment.
Primary	Social paranoia	State Social Paranoia Scale (SSPS)	1 week before and 1 week after treatment.
Secondary	Self-esteem	Rosenberg Self-Esteem scale (RSES)	1 week before, and 10 minutes after treatment.
Secondary	Psychotic symptoms	Brief Psychiatric Rating Scale (BPRS)	1 week before and 1 week after treatment.
Secondary	The experience of presence	Gatineau Presence Questionnaire (GPQ)	10 minutes after treatment
Secondary	Unwanted side effect	Virtual Reality Sickness Questionnaire (VRSQ)	10 minutes before and 10 minutes after treatment